Events

Rappel de Fixed Offset Adapter, A642100

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Ossur North America Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    66609
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0362-2014
  • Date de mise en oeuvre de l'événement
    2013-10-24
  • Date de publication de l'événement
    2013-11-19
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-06-17
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122724
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Component, external, limb, ankle/foot - Product Code ISH
  • Cause
    Ossur inititated a voluntary recall of the a-642100 fixed offset adapter because it can develop fatigue cracks in normal use over an extended period of time and ultimately separate completely.
  • Action
    Ossur sent an "Safety Notice Voluntary Product Recall" letter dated October 29, 2013, via regular mail. Follow-up telephones are also made. The letter identified the product the problem and the actions to be taken by the customer. ¿ssur is committed to providing superior customer service and we will do our utmost to minimize any inconvenience this may cause your practice. To ensure patient safety we kindly ask you to take the following action: " Please identify the users of each of the A-642100 adapters, see attached list. " Also, please check your inventory for any A-642100s you may have on hand but have not fitted on users. A follow-up phone call will be made a few days later to coordinate replacements. A new replacement component will be provided to the customer. For further questions please call (949) 360-3634.

Device

Fixed Offset Adapter, A642100
  • Modèle / numéro de série
    Item Number: A-642100    All Serial Numbers.
  • Classification du dispositif
    Physical Medicine Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution including the states of AL, TX, NY, CA, VA, GA, WI, NC, ID and NJ.
  • Description du dispositif
    Fixed Offset Adapter, A-642100. || The Offset Adapter is a fixed modular component which sets the tube 14.5 mm (0.57 inch) offset from the center line of the pyramid. It is made of a high-strength alloy with a pyramid receiver and is intended where there is a need to offset the tube horizontally in relation to other components. It is fully compatible with all standard 30mm prosthetic pylons. (3) Offset: 14,5mm (0.57inch).
  • Manufacturer
    Ossur North America Inc

Manufacturer

Ossur North America Inc
  • Adresse du fabricant
    Ossur North America Inc, 27051 Towne Centre Dr, Foothill Ranch CA 92610-2804
  • Société-mère du fabricant (2017)
    Össur hf
  • Source
    USFDA